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Current CVB Notices

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Year of Publication

2024 | 2023 | 2022 | 2021 | 2020 | 2019 | 2018 | 2017 | 2016 | 2015 | 2014

2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003

2002 | 2001 | 1999

CVB Notices - 2024

ID Title

24-01 Request Input on Proposed Enhancement for Export Certification

24-02 Issuance of Licenses

24-03

Veterinary Vaccines and Veterinary Diagnostic Products Targeting Avian

Metapneumovirus (all subtypes)

24-04

Posting of Selected Center for Veterinary Biologics Notices and Veterinary

Services Memoranda on the Center for Veterinary Biologics Web Site for

Comment

24-05

Availability of a Pilot Project to Implement a Focused Review Option for

Review of Outlines of Production Submitted through the NCAH Portal

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CVB Notices - 2023

ID Title

90

Veterinary Biological Products in Licensed Establishments Produced and

Destroyed 01/01/2022 through 12/31/2022
CVB Notices - 2023

23-01 Issuance of Licenses

23-02 Issuance of a Conditional License for American Foulbrood

23-03 Change of True Name for antivenin products

23-04

Availability of Duck Atadenovirus 1 (DAdV-1; aka Egg drop 76, adenovirus

127, duck adenovirus) genetic sequence and isolate

23-05

Notification of U.S. Department of Agriculture’s (USDA) Sources Sought

Notice (SSN) for Foreign Animal Disease (FAD) Diagnostic Products

23-06 Antimicrobial Resistance (AMR) Genes in Veterinary Biological Products

23-07 Sale of Unlicensed Autologous Therapeutic Biologics

23-08 Update for Documenting Appropriate Details for Potency Tests

23-09 Issuance of Licenses

23-10

Inclusion of Master Seed, and Master Cell Labels with Submissions to the

Center of Veterinary Biologics (CVB) Laboratory

23-11

Killed/Non-viable Veterinary Vaccines and Veterinary Diagnostic Products

Targeting Egg Drop Syndrome in Chickens

23-12 Issuance of a Conditional License for Canine Parvovirus Monoclonal Antibody

23-13 Issuance of Licenses

23-14 Issuance of Licenses

23-15 Issuance of a Conditional License for Rabbit Hemorrhagic Disease Virus

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CVB Notices - 2022

ID Title

89

Veterinary Biological Products in Licensed Establishments Produced and

Destroyed 01/01/2021 through 12/31/2021

22-01 Issuance of Licenses

22-02 Availability of Avian Influenza Isolate and Sequence Information

22-03

Extended use of currently approved, non-Single Tier compliant domestic

labels

22-04

Discontinued Availability of Erysipelothrix rhusiopathiae Rabbit Polyclonal

Antibody (Detection Antibody)

22-05 Issuance of a Conditional License for Mink Coronavirus

22-06 Issuance of Licenses
CVB Notices - 2022

22-07 Issuance of Licenses

22-08

Review of Labels for Use in Countries that are Members or Observers of the

Veterinary International Conference on Harmonization

22-09 Issuance of Licenses

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CVB Notices - 2021

ID Title

88

Veterinary Biological Products in Licensed Establishments Produced and

Destroyed 01/01/2020 through 12/31/2020

21-01 Issuance of Licenses

21-02 Record Audit Inspections

21-03 Issuance of Inspection Certificate

21-04 Issuance of Licenses

21-05 Supply Chain Disruptions Associated with the COVID-19 Pandemic

21-06 Issuance of Licenses

21-07

Updated Process for Video Submission for Virtual Inspections related to

Remodeled or New Facilities for Existing Licensed Establishments

21-08 Issuance of Licenses

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CVB Notices - 2020

ID Title

87

Veterinary Biological Products in Licensed Establishments Produced and

Destroyed 01/01/2019 through 12/31/2019

20-01 Issuance of Licenses

20-02 NCAH Portal Functionality: Electronic Labeling Submission Revision

20-03 Issuance of Licenses

20-04

Issuance of Licenses

20-05

Name Change for Biologicals containing Glaesserella parasuis, formerly

Haemophilus parasuis, and Clostridioides difficile, formerly Clostridium

difficile
CVB Notices - 2020

20-06

Virtual Inspections for Remodeled or New Facilities for Existing Licensed

Establishments

20-07

Issuance of a Conditional License for Epizootic Bovine Abortion Agent

Vaccine, Live Culture

20-08

Update to Equine Parvovirus Extraneous Agent Testing Requirement for

Equine-Origin Antibody, Antitoxin, Antivenin, Serum, and Plasma Biological

Products Regulated by APHIS

20-09

Issuance of Licenses

20-10

Certification of Veterinary Vaccines and Immunotherapeutics as Containing

Genetically Modified Organisms

20-12

Veterinary Vaccines Targeting SARS-CoV-2 Virus in Mink

20-13

Use of Nonproprietary Names from the United States Adopted Names (USAN)

Council as True Names for Veterinary Biologic Immunotherapeutics

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CVB Notices - 2019

ID Title

86

Veterinary Biological Products in Licensed Establishments Produced and

Destroyed 01/01/2018 through 12/31/2018

19-01 Issuance of Licenses

19-02 Issuance of Licenses

19-03

New Extraneous Agent Testing Requirement for Equine-Origin Antibody,

Antitoxin, Serum, and Plasma Products Regulated by APHIS

19-04

Name Change for Biologicals Containing Mycobacterium avium subspecies

paratuberculosis, formerly Mycobacterium paratuberculosis

19-05

Name Change for In Vitro Diagnostics (Test Kits) Intended to Detect Canine

or Feline Heartworm Antigen
CVB Notices - 2019

19-06 Issuance of Licenses

19-07 Discontinued Availability of Pasteurella multocida 169 (Porcine) Bacterin

19-09 Availability of Newcastle Disease Isolate and Sequence Information

19-10

Expanded NCAH Portal Functionality: APHIS Form 2005 Applications for Sale

and Distribution

19-11

Expanded NCAH Portal Functionality: APHIS Form 2005 Applications for

Research and Evaluation, and Transit Shipment Permits

19-12 Issuance of a Conditional License for Avian Reovirus Vaccine, Killed Virus

19-13 Issuance of Licenses

19-14 Extension of Implementation Period of Single Tier Label Claim

19-15 Availability of New Inactivated Veterinary Rabies Reference

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CVB Notices - 2018

ID Title

85

Veterinary Biological Products in Licensed Establishments Produced and

Destroyed 01/01/2017 through 12/31/2017

18-01 Issuance of Licenses

18-02

Issuance of a Conditional License for Avian Paramyxovirus Vaccine, Type 1,

Killed Virus

18-03 Changes in True Names Based on Accepted Nomenclature

18-04 Expanded NCAH Portal Functionality: Submission of Export Documents

18-05 Detection of Senecavirus A in Veterinary Biological Products

18-06 Issuance of Licenses

18-07 Digital Signatures on Microsoft Word Documents

18-08 Expanded NCAH Portal Functionality: Submission of Facility Documents

18-09 Implementation Period for the Submission of Adverse Event Reports

18-10 Issuance of Licenses

18-11

Policy for Long-Term Recognition of CVB Digital Signatures in Microsoft

Word documents

18-12 Issuance of Licenses

18-13 Labeling of Vaccines Containing Porcine Circovirus Type 2

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CVB Notices - 2017

ID Title

84

Veterinary Biological Products in Licensed Establishments Produced and

Destroyed 01/01/2016 through 12/31/2016

17-01 Issuance of Licenses

17-02 Issuance of a Conditional License for Moraxella Bovoculi Bacterin

17-03

Expanded NCAH Portal Functionality: Electronic Outlines of Production and

Special Outlines

17-04 Availability of Avian Influenza Isolate and Sequence Information

17-05 Issuance of Licenses

17-06

Option to Remove Back-titration Hamsters from In Vivo Potency Tests for

Leptospira Serogroups Pomona and Grippotyphosa

17-07 Transfer of Availability of Cell Lines from the Center for Veterinary Biologics

17-08

Retention of Policy Documents Posted to Center for Veterinary Biologics

Website

17-09 Issuance of Licenses

17-10

Discontinued Availability of Diagnostic Test Kit Serial Release Panels

Obtained from the Center for Veterinary Biologics (CVB)

17-11

Facility Documents Processing Changes – Pilot Project

17-12 Issuance of Licenses

17-13 Revised Scope of Eligibility for Studies Requiring Single-Tier Summaries

17-15 Center for Veterinary Biologics Laboratory-supplied Reagents

17-16

Issuance of a Conditional License for Canine Osteosarcoma Vaccine, Live

Listeria Vector

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CVB Notices - 2016

ID Title

16-02 Availability of Avian Influenza Isolate and Sequence Information

16-03 Veterinary Biologics Containing Senecavirus A

16-05

Initiation of the National Centers for Animal Health (NCAH) Portal for the

Center for Veterinary Biologics

16-07 In-depth Inspection Report Format
CVB Notices - 2016

16-12

Name Change for Biologicals Containing Haemophilus paragallinarum,

Babesia equi, and Ehrlichia risticii

16-13 Cancellation of Veterinary Services Memorandum 800.90 and 800.92

16-14

Expansion of the National Centers for Animal Health (NCAH) Portal for the

Center for Veterinary Biologics

16-15 Implementation of Single Label Claim and Labeling/Packaging Rules

16-16 Issuance of Licenses

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CVB Notices - 2015

ID Title

15-03 Adjustment for Clostridium perfringens Type C and Type D Reagents

15-04

Nomenclature and Level of Identification Required for Leptospira Master

Seed Bacteria and Challenge Cultures

15-06 Availability of Canine Influenza Virus Subtype H3N2

15-07 Availability of Avian Influenza Isolates

15-08 Changes to the Administrative Inspection Review Program

15-13

Option to Remove Back-titration Hamsters from In Vivo Potency Tests for

Leptospira Serogroups Canicola and Icterohaemorrhagiae

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CVB Notices - 2014

ID Title

14-06

Safety Data to Support Using Multiple Strains of Potentially

Immunosuppressive Viruses in the Same Modified Live Product

14-10 Change in Distribution Policy for Memoranda and Notices

14-16 Processing Special Outlines Describing Proposed Serial Release Assays

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CVB Notices - 2013

ID Title

13-02 Quarterly Acknowledgement Summaries for Selected Submissions

13-05

Use of Polymerase Chain Reaction (PCR) Assays to Measure Potency of

Inactivated Protein-Based Biologicals
CVB Notices - 2013

13-06

Reporting Inactivation Test Results on APHIS Forms 2008 for Inactivated

Veterinary Biological Products with the Restriction "For Further Manufacture

(FFM)"

13-10 Changes to the Rabies Virus NIH Potency Test Validity Requirements

13-17 Summary of Changes for Related Study Protocols

13-18 Discontinuing the Use of RelPot Software

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CVB Notices - 2012

ID Title

12-

03

Exemption to Shipping a Sample of Inactivated Lot or Bulk Rabies Antigen to

the Center for Veterinary Biologics

12-

04

Appropriate Use of Controls for Chicken Anemia Virus Extraneous Agent

Testing, Availability of a PCR-based Testing Protocol, and Availability of a New

Testing Reagent (Referenced Documents: VIRPRO0118 and VIRNPP0001)

12-

05

Testing Exemptions for Antibody Product Donor Animals

12-

06

Detection of Mycoplasma Contamination in Vaccines and Biological Products

12-

07

Submission of Master Seeds, Master Cell Stocks, and Master Sequences to the

Center for Veterinary Biologics for Confirmatory Testing

12-

09

Licensing of Vaccines as Preharvest Food Safety Interventions

12-

11

Virulent Systemic Feline Calicivirus Label Claims

12-

12

Use of Humane Endpoints and Methods in Animal Testing of Biological

Products

12-

21

Conducting Dilution of Preservative Studies for Live Bacterial Vaccines

12-

25

New Policy on Biological Product Samples Submitted to the Center for

Veterinary Biologics and Concurrent Testing Selection Period

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CVB Notices - 2011

ID Title
CVB Notices - 2011

11-01

The Management and Disposition of Eggs, Chickens, and Biological Products

Following a Chicken Anemia Virus (CAV) Outbreak in a Source Flock

11-02 Generation and Implementation of Draft Guidance

11-12 Product Licensing Plans

11-14 superseded by CVB Notice 15-02

11-18

Virus Inactivation and Safety Test for Rabies Virus Bulks, Title 9, Code of

Federal Regulations (9 CFR), Part 113.209

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CVB Notices - 2010

ID Title

10-10 Follow-up Sterility Check Testing

10-11

Obtaining the Testing Plan for Authorized Master Seed/Master Cell Sample

Submissions

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CVB Notices - 2009

ID Title

09-02 Dilution of Preservative Screening for Broth-Based Sterility Tests

09-04 Conversion Formulas for S/P Ratio to Titer in Diagnostic Test Kit Inserts

09-05

Consistency of Avian Safety Testing Parameters in Outlines of Production

for Multi-fraction Avian Products

09-15 Autogenous Vaccines Containing Porcine Circovirus

09-25 Dilution of Preservative Screening for Plate-Based Sterility Tests

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CVB Notices - 2008

ID Title

08-19 Electronic Maintenance of Paper Records

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CVB Notices - 2007

ID Title

07-04 Submission of Outsourced Studies
CVB Notices - 2007

07-06

Preparation and Testing of Experimental Biological Products that are

Derived from Biotechnology

07-07 Post-Challenge Observation Periods for Efficacy Studies

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CVB Notices - 2006

ID Title

06-

03

Potential Contamination of Porcine Kidney Cells

06-

06

Type (Species) Designation of Vaccines Containing Bovine Viral Diarrhea

Virus(es)

06-

11

Replacement of Potency Assay Reference Samples for Immunodiagnostic Test

Kits

06-

24

Exemptions to allow live poultry vaccines administered via wing web to be

tested for detection of extraneous viable bacteria and fungi via Title 9, Code

of Federal Regulations, Part 113.27 (e)

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CVB Notices - 2005

ID Title

05-06 Requirements for Addition of Leptospira bratislava in Canine Bacterins

05-07 Biologics for Reduction of Colonization and/or Shedding in Animals

05-16

Posting of Selected Center for Veterinary Biologics Notices and Veterinary

Services Memoranda on the Center for Veterinary Biologics Web Site for

Comment

05-23 Chimera as an Additional Naming Convention for Live Recombinant Products

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CVB Notices - 2004

ID Title

04-13 Use of Minimum Age Animals in Licensure Studies

04-16 Efficacy Requirements and Label Claims for Bovine Rotavirus Vaccine

04-17 Exemption to 3-year Master Seed Immunogenicity Retesting

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CVB Notices - 2003
ID Title

03-08

Purpose of the Equine Infectious Anemia Weak Positive Serum Sample

Outlined in Veterinary Services Memorandum No. 555-16

03-13 Detection of Avian Lymphoid Leukosis Virus in Veterinary Biological Products

03-14 Customer Feedback on Reagents

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CVB Notices - 2002

ID Title

02-01 Critical Study Dates for Licensing and Reference Qualification Studies

02-15

Permit Requirements for Pathogenic Organisms, Including Challenge

Materials

02-21

Domestic Manufacture of Biologicals Used in the Prevention or Treatment

of Foreign Animal Diseases

02-25

Conditional Licenses for Products Containing Clostridium perfringens Type

A

02-29

Availability of Monoclonal Antibodies from the Center for Veterinary

Biologics

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CVB Notices - 2001

ID Title

01-07

Identification of Testing Methods for Detection of Extraneous Agents in Fetal

Bovine Serum

01-11

International Cooperation on Harmonization of Technical Requirements for

the Registration of Veterinary Medicinal Products (VICH): Final Guidelines for

Good Clinical Practice

01-16 Autogenous Products for Avian Influenza

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CVB Notices - 1999

ID Title

99-19 Autogenous Virus Vaccines for Infectious Salmon Anemia Virus

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